Everolimus eluting bioresorbable vascular scaffolds in patients with acute coronary syndromes: Two‐year results from the German‐Austrian ABSORB registry

Abstract Objectives To identify potential differences in 2‐year outcome between patients who underwent coronary revascularization using bioresorbable vascular scafffolds (BVS) in stable coronary artery disease (CAD) and acute coronary syndromes (ACS). Background Data from randomized trials suggest a significantly higher event rate following coronary revascularization using everolimus‐eluting BVS as compared to new generation drug eluting stents. Whether particular patient subgroups are at increased risk for scaffold thrombosis and target lesion failure (TLF) has not clearly been demonstrated. Methods German‐Austrian ABSORB RegIstRy is a prospective all‐comer multi‐center observational study…

Primary endpoint results of the OMEGA Study: One-year clinical outcomes after implantation of a novel platinum chromium bare metal stent.

Bare metal stents (BMS) have similar rates of death and myocardial infarction (MI) compared to drug-eluting stents (DES). DES lower repeat revascularization rates compared to BMS, but may have higher rates of late stent thrombosis (ST) potentially due to impaired endothelialization requiring longer dual anti-platelet therapy (DAPT). OMEGA evaluated a novel BMS designed to have improved deliverability and radiopacity, in comparison to currently available platforms.OMEGA was a prospective, multicenter, single-arm study enrolling 328 patients at 37 sites (US and Europe). Patients received the OMEGA stent (bare platinum chromium element stent) for the treatment of de novo native coronary artery…

The German CPU Registry: Comparison of troponin positive to troponin negative patients

Lars S. Maier ⁎, Harald Darius , Evangelos Giannitsis , Raimund Erbel , Michael Haude , Christian Hamm , Gerd Hasenfuss , Gerd Heusch , Harald Mudra , Thomas Munzel , Claus Schmitt , Burghard Schumacher , Jochen Senges , Thomas Voigtlander , Jan B. Schuttert a a Dept. of Cardiology & Pneumology/Heart Centre, Georg-August-University, Gottingen, Germany b Dept. of Cardiology, Angiology & Intensive Care Medicine, Vivantes Hospital Neukolln, Berlin, Germany c Dept. of Cardiology, Angiology & Pneumology, Ruprecht-Karls-University, Heidelberg, Germany d Dept. of Cardiology, West-German Heart Centre, University of Essen, Germany e Dept. of Cardiology & Nephrology, Lukas Hospital, Neuss, Germany f …

P798Outcome of percutaneous coronary intervention with everolimus-eluting bioresorbable vascular scaffolds in patients with STEMI as compared to stable CAD 2 year results from the German-Austrian ABSORB

Predictors of early scaffold thrombosis: results from the multicenter prospective German-Austrian ABSORB RegIstRy.

BACKGROUND In randomized clinical trials, the risk of thrombotic events with the absorb bioresorbable vascular scaffold (BVS) was significantly higher than with metallic drug-eluting stents. We evaluated predictors of scaffold thrombosis in the large-scale, multicenter German-Austrian ABSORB RegIstRy. METHODS AND RESULTS 3178 patients with treatment of 4252 lesions using 5020 scaffolds were included. Follow-up rate at 6 months was 97.4%. Forty-five (1.42%) patients experienced definite/probable scaffold thrombosis during follow-up. Multiple regression analysis showed implantation of absorb BVS in bifurcation lesions [odds ratio (OR): 4.43; 95% confidence interval (CI): 1.69-11.59; P=0.0024]…

Pulmonary endarterectomy in chronic thromboembolic pulmonary hypertension.

Management and outcome of patients with operable chronic thromboembolic pulmonary hypertension (CTEPH) who underwent pulmonary endarterectomy (PEA) at a large German referral center were investigated.In Germany, 394 PEAs were performed in 2014 and 2015 with an in-hospital mortality rate of 5.8%. Of these, 253 patients (64.2%) were treated at the Kerckhoff Clinic, Bad Nauheim, and 237 (93.7%; median age, 62 years [interquartile range [IQR], 52-72 years]; 46.0% female) were included in the present analysis.On referral, 52 patients (22.0%) were treated with pulmonary arterial hypertension-specific drugs and 95 (40.4%) were treated with non-vitamin K-dependent oral anticoagulants, and 14 (5.9%)…

The German CPU Registry: Dyspnea independently predicts negative short-term outcome in patients admitted to German Chest Pain Units.

While dyspnea is a common symptom in patients admitted to Chest Pain Units (CPUs) little is known about the impact of dyspnea on their outcome. The purpose of this study was to evaluate the impact of dyspnea on the short-term outcome of CPU patients.We analyzed data from a total of 9169 patients admitted to one of the 38 participating CPUs in this registry between December 2008 and January 2013. Only patients who underwent coronary angiography for suspected ACS were included. 2601 patients (28.4%) presented with dyspnea.Patients with dyspnea at admission were older and frequently had a wide range of comorbidities compared to patients without dyspnea. Heart failure symptoms in particular wer…

Evaluation of the short- and long-term safety and therapy outcomes of the everolimus-eluting bioresorbable vascular scaffold system in patients with coronary artery stenosis: Rationale and design of the German–Austrian ABSORB RegIstRy (GABI-R)

Abstract Background Third-generation drug-eluting metal stents are the gold standard for treatment of coronary artery disease. The permanent metallic caging of the vessel, however, can result in limited vasomotion, chronic inflammation, and late expansive remodeling, conditions that can lead to late and very late stent thrombosis. The development of bioresorbable scaffolds (BRSs) promises advantages over metal stents due to complete biodegradation within 2–4 years. Theoretically, since vessel scaffolding is temporary and no permanent implant remains in the vessel, BRSs, as opposed to metal stents, once degraded would no longer be potential triggers for stent-related adverse events or side e…

Predictors of scaffold failure and impact of optimized scaffold implantation technique on outcome: Results from the German-Austrian ABSORB RegIstRy.

Aims We aimed to investigate predictors of scaffold failure and the potential impact of an optimized scaffold implantation technique by means of a learning curve on long-term clinical outcome after bioresorbable scaffold (BRS) implantation and to evaluate predictors of scaffold failure. Methods and results A total of 3326 patients were included in this prospective, observational, multi-center study (ClinicalTrials.gov NCT02066623) of consecutive patients undergoing BRS implantation between November 2013 and January 2016. The 3144 patients completed follow-up after 24 months, 3265 patients were eligible for time-to-event-analysis. Clinical endpoints were major adverse cardiac events-a compos…

Release kinetics of early ischaemic biomarkers in a clinical model of acute myocardial infarction

ObjectiveTo determine the release kinetics of different biomarkers with potential as novel early ischaemic biomarkers in patients with acute coronary syndrome (ACS); it is difficult to establish the detailed release kinetics in patients with acute myocardial infarction (AMI).MethodsWe analysed the release kinetics of soluble fms-like tyrosine kinase (sFlt-1), ischaemia modified albumin (IMA), and heart-type fatty acid binding protein (hFABP) in patients with hypertrophic obstructive cardiomyopathy who were undergoing transcoronary ablation of septal hypertrophy (TASH), a procedure mimicking AMI. Consecutive patients (n=21) undergoing TASH were included. Blood samples were collected before T…

Prediction of Acute Kidney Injury after TAVI by New Biomarkers

No difference in 30-day outcome and quality of life in transradial versus transfemoral access – results from the German Austrian ABSORB registry (GABI-R)

Abstract Background Radial (RA) instead of femoral access (FA) for coronary interventions has become a European Society of Cardiology Class-IA guideline recommendation. But when the decision on the access site is left to the discretion of the operator, differences in adverse event rates mitigate. Methods We compared the 30-day outcome for RA and FA in all patients recruited for the observational German Austrian ABSORB Registry (GABI-R) in regard to all-cause mortality, stroke, myocardial infarction (MI), TIMI major bleedings (TMB) and quality of life (QoL). All patients were treated with a bioresorbable vascular scaffold. Access site was left to the discretion of the operator. Results In to…

Non-Invasive Approach for Evaluation of Pulmonary Hypertension Using Extracellular Vesicle-Associated Small Non-Coding RNA.

Extracellular vesicles are released by numerous cell types of the human body under physiological but also under pathophysiological conditions. They are important for cell&ndash

Angiographic follow-up results of a randomized study on angioplasty versus bypass surgery (GABI Trial)

Although several randomized trials have been performed to compare the outcomes of percutaneous transluminal coronary angioplasty (PTCA) and coronary artery bypass surgery (CABG) in patients with multivessel disease, there is little data available on angiographic follow-up results. The present substudy of the German angioplasty versus bypass surgery investigation (GABI Trial) compares the angiographic revascularization status in these two cases 6 months after treatment. Follow-up angiograms were available in 102 CABG patients and 117 PTCA patients. Although the protocol excluded patients with total occlusion, on follow-up 6 months after treatment we found total occlusion of 94 native arterie…

Mid-regional pro-atrial natriuretic peptide and copeptin as indicators of disease severity and therapy response in CTEPH

Background Chronic thromboembolic pulmonary hypertension (CTEPH) leads to right heart failure. Pulmonary endarterectomy (PEA) or balloon pulmonary angioplasty (BPA) restore pulmonary haemodynamics and allow cardiac recovery. This study examined the relationship of copeptin and mid-regional pro-atrial natriuretic peptide (MR-proANP) levels to disease severity and therapy response. Methods This observational cohort study included 125 patients (55 PEA/70 BPA) who underwent treatment and completed a 6-/12-month follow-up. Biomarkers, measured at baseline, prior to every BPA and at follow-up, were compared to 1) severe disease at baseline (right atrial pressure (RAP) ≥8 mmHg and cardiac index ≤2…

Hybrid Coronary Percutaneous Treatment with Metallic Stents and Everolimus-Eluting Bioresorbable Vascular Scaffolds: 2-years Results from the GABI-R Registry

The limitations of the first-generation everolimus-eluting coronary bioresorbable vascular scaffolds (BVS) have been demonstrated in several randomized controlled trials. Little data are available regarding the outcomes of patients receiving hybrid stenting with both BVS and drug-eluting stents (DES). Of 3144 patients prospectively enrolled in the GABI-Registry, 435 (age 62 &plusmn

Identification of acute myocardial infarction in elderly patients using optimized highly sensitive troponin I thresholds

Purpose: Established diagnostic thresholds for high-sensitivity cardiac troponins (hs-cTn) might not apply for elderly patients as they are elevated irrespective of the presence of an acute myocardial infarction (AMI). Aim of the present study was to investigate hs-cTnI in elderly patients with suspected AMI and to calculate optimized diagnostic cutoffs. Material and methods: Data from a prospective multi-centre study and from a second independent prospective single-centre cohort study were analysed. A number of 2903 patients were eligible for further analysis. Patients > 70 years were classified as elderly. hs-cTnI was measured upon admission. Results: Around 34.7% of 2903 patients were…

Self-referral to chest pain units: results of the German CPU-registry

Chest pain units (CPUs) are increasingly established in emergency cardiology services. With improved visibility of CPUs in the population, patients may refer themselves directly to these units, obviating emergency medical services (EMS). Little is known about characteristics and outcomes of self-referred patients, as compared with those referred by EMS. Therefore, we described self-referral patients enrolled in the CPU-registry of the German Cardiac Society and compared them with those referred by EMS.From 2008 until 2010, the prospective CPU-registry enrolled 11,581 consecutive patients. Of those 3789 (32.7%) were self-referrals (SRs), while 7792 (67.3%) were referred by EMS. SR-patients w…

TCT-34 Prediction of acute kidney injury after TAVR by new biomarkers

Acute kidney injury (AKI) is a common complication after transcatheter aortic valve replacement (TAVR) and is associated with increased morbidity and mortality. Routinely used biomarkers such as creatinine show a diagnostic gap in the first hours after kidney injury. Thus, new biomarkers for earlier

Impact of coronary calcification on outcomes after ABSORB scaffold implantation: insights from the GABI-R registry.

OBJECTIVE To investigate the outcomes after bioresorbable scaffold (BRS) implantation in calcified coronary lesions. In calcified coronary lesions, durable metallic drug-eluting stent (DES) implantation is associated with worse clinical outcomes compared to noncalcified lesions. Although not recommended, BRSs were frequently implanted in calcified lesions in clinical practice. Their outcome is not well investigated. METHODS Between November 2013 and January 2016, 3326 patients were enrolled in the German-Austrian ABSORB ReglstRy (GABI-R). Lesion calcification severity was classified into no (n = 1144), mild (n = 1306), and moderate-to-severe (n = 690) calcification. RESULTS Patients with ca…